Streptococcus PneumoniaeNCT06096025
Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream Infections
An observational study of Streptococcus Pneumoniae, run by Methodist Health System at 1 site in United States.
Trial summary
Streptococcus pneumoniae is a gram-positive (GP) bacteria responsible for common infections such as community-acquired pneumonia (CAP), as well as complicated infections such as bacteremia, infective endocarditis and meningitis. S. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Streptococcus Pneumoniae
- What is being tested?
- pneumoniae bacteremia therapy
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2023to 23 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients ≥18 years of age * S. pneumoniae isolated from ≥1 blood cultures * Active IV antibiotic therapy within 48 hours of the first positive blood culture(7,8) * Clinical stability by day 10 of therapy
Who may be able to join
- • ≥18 years of age
- S. pneumoniae isolated from ≥1 blood cultures
- Active IV antibiotic therapy within 48 hours of the first positive blood culture(7,8)
- Clinical stability by day 10 of therapy
Who cannot join
- • Treatment duration <5 days or >16 days
- Death before completion of therapy (<10 days vs. ≥ 10 days )
- Polymicrobial BSI
- Invasive infection caused by S. pneumoniae (endocarditis, meningitis, and lung abscess)
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream
Streptococcus pneumoniae is a gram-positive (GP) bacteria responsible for common infections such as community-acquired pneumonia (CAP), as well as complicated infections such as bacteremia, infective endocarditis and meningitis. S. pneumoniae bacteremia ranks among the top 10 most common pathogens associated with bloodstream infections and correlates with high morbidity and mortality worldwide.
Read the detailed description
The Infectious Diseases Society of America (IDSA) guidelines for CAP management advocate for short courses of antibiotics for CAP treatment. However, it does not address duration of therapy for common CAP pathogens such as S. pneumoniae when associated with blood stream infections (BSI). 3
Currently, GP bacteremia duration of therapy typically ranges from 7 to 14 days based on IDSA guideline recommendations for Staphylococcus aureus bacteremia with no further definitive consensus.4 Additionally, lack of data and randomized clinical trials on the efficacy and safety of short compared to long treatment duration have led to variability in practice. Most randomized clinical trials as well as retrospective studies on treatment duration, have been conducted mainly in gram-negative BSI
- Conditions
- Streptococcus Pneumoniae
- Being tested
- pneumoniae bacteremia therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumoniae bacteremia therapyDrug
Also called Total antibiotic treatment duration
To evaluate the effectiveness of short 10 days versus long (≥10 days) duration of therapy associated with S. pneumoniae bacteremia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection related-hospitalization
hospital readmission with streptococcal pneumonia, bacteremia, endocarditis, meningitis, and lung abscess within 30 days of antibiotic completion
Measured: 30 days
Recurrence
Reinfection with streptococcal pneumonia, within 30 days of antibiotic completion
Measured: 30 days
All-cause mortality
Death within 30 days of antibiotic completion
Measured: 30 days
Secondary outcomes (5)
ICU Length of stay(LOS)
length of ICU stay
Measured: 30 days
Hospital LOS
length of hospital stay
Measured: 30 days
Occurrence of C. difficile infection
Number of times of C.difficile infections
Measured: 30 days
Total antibiotic treatment duration
Number of times of antibiotic treatment duration
Measured: 30 days
Central venous catheter placement
placement of venous catheter
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start23 Jun 2023
- Primary completion23 Jun 2026 (estimated)
- Study completion23 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus PneumoniaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Crotty, PharmD, Principal investigator, Methodist Midlothian Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096025
- Sponsor's protocol ID
- 026.PHA.2023.A
- Status last verified
- Jul 2025
- First submitted
- 17 Oct 2023
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI is committed to disseminate research results in a timely fashion. Sharing of data generated by this project will be carried out through presentation at scientific meetings and/or publication in Open Access Journals.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Versus Long Duration of Therapy for Streptococcus Pneumoniae Bloodstream
- ClinicalTrials.gov ID
- NCT06096025
- Acronym / sponsor ID
- 026.PHA.2023.A
- Conditions
- Streptococcus Pneumoniae
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 23 Jun 2026 (estimated)
- Study completion
- 23 Jun 2026 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Streptococcus pneumoniae is a gram-positive (GP) bacteria responsible for common infections such as community-acquired pneumonia (CAP), as well as complicated infections such as bacteremia, infective endocarditis and meningitis. S. pneumoniae bacteremia ranks among the top 10 most common pathogens associated with bloodstream infections and correlates with high morbidity and mortality worldwide.
Detailed description
The Infectious Diseases Society of America (IDSA) guidelines for CAP management advocate for short courses of antibiotics for CAP treatment. However, it does not address duration of therapy for common CAP pathogens such as S. pneumoniae when associated with blood stream infections (BSI). 3
Currently, GP bacteremia duration of therapy typically ranges from 7 to 14 days based on IDSA guideline recommendations for Staphylococcus aureus bacteremia with no further definitive consensus.4 Additionally, lack of data and randomized clinical trials on the efficacy and safety of short compared to long treatment duration have led to variability in practice. Most randomized clinical trials as well as retrospective studies on treatment duration, have been conducted mainly in gram-negative BSI
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients ≥18 years of age * S. pneumoniae isolated from ≥1 blood cultures * Active IV antibiotic therapy within 48 hours of the first positive blood culture(7,8) * Clinical stability by day 10 of therapy
Key inclusion criteria (4 listed)
- • ≥18 years of age
Key exclusion criteria (4 listed)
- • Treatment duration <5 days or >16 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pneumoniae bacteremia therapyAlso: Total antibiotic treatment durationTo evaluate the effectiveness of short 10 days versus long (≥10 days) duration of therapy associated with S. pneumoniae bacteremia. | Drug | – |
Primary outcome
Infection related-hospitalization
Time frame: 30 days
hospital readmission with streptococcal pneumonia, bacteremia, endocarditis, meningitis, and lung abscess within 30 days of antibiotic completion
Recurrence
Time frame: 30 days
Reinfection with streptococcal pneumonia, within 30 days of antibiotic completion
All-cause mortality
Time frame: 30 days
Death within 30 days of antibiotic completion
5 secondary outcomes
ICU Length of stay(LOS)
Time frame: 30 days
Hospital LOS
Time frame: 30 days
Occurrence of C. difficile infection
Time frame: 30 days
Total antibiotic treatment duration
Time frame: 30 days
Central venous catheter placement
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Yes. The PI is committed to disseminate research results in a timely fashion. Sharing of data generated by this project will be carried out through presentation at scientific meetings and/or publication in Open Access Journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Crotty, PharmD principal investigator
Methodist Midlothian Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Pneumoniae, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection related-hospitalization (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.